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Study of Provent Treatment of Obstructive Sleep Apnea in Patients Who Are Non-compliant With CPAP - NCT00901771-63017(Clinical Trial 292150)



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City:  Chesterfield
State:  
MO
Zip Code: 63017
Conditions: Sleep Apnea, Obstructive
Purpose: The primary objective of the proposed investigation is to evaluate the efficacy of the Provent device in a sample of OSA patients who have either refused or been non-adherent with PAP treatment. Both initial efficacy (evaluated after approximately one week with Provent) and efficacy after approximately 5 weeks in patients who demonstrate initial efficacy will be assessed. A secondary objective is to assess adherence with Provent treatment during the 5-week evaluation period.
Study summary:
Criteria: Inclusion Criteria: - Current signs and symptoms consistent with a diagnosis of OSA in the opinion of the study physician - Rejection of PAP treatment or minimally adherent with PAP treatment - Use of the Provent device for a specified amount of time each night during three consecutive nights of the trial period - AHI > 15, or AHI > 10 with evidence of CMS-recognized symptoms or co- morbidities, on screening/baseline PSG - Investigator believes that subject can benefit from OSA treatment - Subject understands and is willing and able to comply with study requirements Exclusion Criteria: - Use of any device that interferes with nasal or oral breathing - Persistent blockage of one or both nostrils which prevents airflow in one or both nostrils - Any chronic sores or lesions on the inside or outside of the nose - Chronic use of nasal decongestants other than nasal steroids - History of allergic reaction to acrylic-based adhesives (such as those found in BAND-AIDS®) - Current acute upper respiratory (including nasal, sinus, or middle ear) inflammation or infection or perforation of the tympanic membrane (may be re-considered for participation after the acute episode resolves) - History of frequent and/or poorly treated severe nasal allergies or sinusitis which may interfere with the ability to use Provent - Severe respiratory disorders (including respiratory muscle weakness, bullous lung disease, bypassed upper airway, pneumothorax, pneumomediastinum, etc.). - Pathologically low blood pressure. - Narcolepsy, idiopathic hypersomnolence, chronic insomnia, restless legs syndrome, REM sleep behavior disorder or any other diagnosed or suspected sleep disorder other than OSA that could affect the likelihood of apneas/hypopneas during a PSG. - Periodic limb movement arousal index (PLMAI) > 10 on the screening/baseline PSG. - Current use of diurnal or nocturnal supplemental oxygen - Currently working night or rotating shifts - Consumption of > 10 caffeinated beverages per day (approximately 1000 mg per day) - History of severe cardiovascular disease, including New York Heart Association Class III or IV heart failure, coronary artery disease with angina or myocardial infarction in the past 6 months, stroke in the past 6 months - History of cardiac rhythm disturbance (defined as a 5-beat run of sustained ventricular tachycardia or bradycardia if < 30 beats per min for a 10-second run or previously undiagnosed and untreated atrial fibrillation or Mobitz II or third-degree heart block) - Current psychiatric disorder with psychotic features. - Pregnant or trying to become pregnant
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Data Source: ClinicalTrials.gov
Date Processed: June 11, 2010
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